BEUDAMED
    19 results · 19ms · Sources: EU EUDAMED, US FDA

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    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

    FDA Recall
    Open, Classified ·NeuMoDx Molecular Inc·Product code QJR·January 21, 2022

    EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·March 4, 2024

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

    FDA Recall
    Open, Classified ·NeuMoDx Molecular Inc·Product code QLT·May 13, 2022

    QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223

    FDA Recall
    Open, Classified ·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QLT·May 19, 2023

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214

    FDA Recall
    Open, Classified ·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QLT·May 19, 2023

    QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·June 3, 2024

    Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code JJH·June 5, 2019

    NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100

    FDA Recall
    Terminated ·NeuMoDx Molecular Inc·Product code QJR·May 4, 2021

    QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAsymphony SP instrument

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·July 2, 2019

    QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code QLT·April 28, 2023

    Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code QOF·March 12, 2025

    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code OOI·January 28, 2020

    QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223

    FDA Recall
    Open, Classified ·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QJR·May 9, 2023

    NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref. Number: 100100

    FDA Recall
    Open, Classified ·NeuMoDx Molecular Inc·Product code QJR·February 18, 2022

    therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code OWG·April 8, 2020

    therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·February 25, 2022

    therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·February 25, 2022

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code QLT·November 8, 2021

    QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code QLT·July 15, 2020